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Prednisone (PRED-ni-sone)
Consumer Medicine Information
Disclaimer
This information answers some common questions about SONE (prednisone tablets).
It does not contain all of the available information about SONE tablets.
It does not replace talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you or your child taking SONE against the benefits he or she expects it will have.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
What is SONE
The name of your medicine is SONE and is available in tablets of two different strengths of 5 mg and 25 mg tablets.
The active ingredient is called prednisone.
Prednisone belongs to a group of medicines called corticosteroids.
Corticosteroids are used to help reduce inflammation in the body or to suppress the immune system in the body, when a disease may be due to an autoimmune reaction (where your body fights against itself).
SONE is available as a 5 mg and 25 mg tablet.
What SONE is used for
SONE is used to treat a number of medical conditions.
• Your doctor will be able to decide.
Ask your doctor if you have any questions about why SONE has been prescribed for you.
If you have any concerns, you should discuss this with your doctor.
This medicine is available only with a doctor's prescription.
Before you take SONE
When you must not take it
Do not take SONE if you are allergic to:
• Prednisone or other cortisone type medications, or any of the ingredients listed at the end of this information piece including lactose.
Some of the symptoms of an allergic reaction to SONE may include urticaria and other skin rashes, difficulty breathing, hay fever, swelling of the face or throat or faintness.
Do not take SONE if you have a peptic ulcer, suffer from osteoporosis (brittle bones) or suffer severe psychoneuroses.
Do not take SONE if you are breastfeeding or plan to breastfeed.
Do not take SONE if you know you have any infections, including mumps, measles or
chickenpox.
Do not use SONE after the expiry date (EXP.) printed on the pack.
If you take it after the expiry date has passed, it may have no effect at all, or worse, there may be an entirely unexpected effect.
Do not purchase or use SONE if the packaging is torn or shows any signs of tampering.
Do not give it to children unless your doctor has prescribed it.
Before you start to take it
You must tell your doctor if:
1. You are allergic to any other medicines or any foods, dyes or preservatives.
2. You have or have had any other medical conditions/ health problems, including:
• suffer from tuberculosis(TB)
• suffer from a stomach ulcer
• suffer from osteoporosis (brittle
bone disease)
• suffer from myasthenia gravis
• suffer from congestive heart failure or have any other heart disease
• have diabetes
• have renal failure (your kidneys have shutdown)
• have an underactive thyroid gland (hypothyroidism)
• have any infection (bacterial or fungal) including viral infections such as chicken pox.
3. Take Typhoid Vaccine.
Live or attenuated vaccines such as oral typhoid vaccine must not be taken with SONE.
4. You are pregnant or plan to become pregnant.
SONE like all medicines should not be used during pregnancy, unless your doctor tells you.
5. You are breastfeeding or plan to breastfeed.
6. You are taking potassium supplements.
7. You are taking some anti-epileptic drugs
8. You are taking growth hormones
9. You are taking digoxin or digitalis glycosides.
10. You are on a course of vaccinations.
If you have not told your doctor about any of the above, tell them before you take any SONE.
Taking other medicines
Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.
Some medicines may interfere with SONE. These include:
• medicines used to treat upset stomachs such as antacids
• medicines used for diabetes including insulin
• medicines used to treat tuberculosis such as rifampicin
• medicines used to treat fungal infections such as ketoconazole
• some medicines which have a high sodium content and also foods with a high sodium content - check with your pharmacist
• some fluid tablets, also called diuretics
• alcohol
• barbiturates, medicine used to treat epilepsy
• high doses of aspirin
The above medicines may either reduce the effectiveness of SONE, reduce its own effectiveness and/or react with SONE resulting in untoward or sometimes dangerous side effects.
SONE will interfere with laboratory tests your doctor may make to check your thyroid. Tell your doctor if you are taking SONE tablets before you undergo any laboratory test.
This list is not exhaustive. Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking SONE.
How to take SONE
a) how much to take
The dose of SONE may be different for each person and their medical condition.
Your doctor will decide the right dose for you.
The recommended doses are for:
• Adults: 10 mg to 100 mg daily in divided doses.
• Children: 1 to 5 years: 2.5 mg to 10 mg twice daily.
• Children: 6 to 12 years: 5 mg to 20 mg twice daily.
However, dosage requirements are variable and are individualised by your doctor based on the treatment you are undergoing and your response to it.
High doses of SONE should be reduced gradually. Your doctor will know how.
b) how to take it
Swallow the medicine with water. If the dose is one-half tablet, there is a break-line on the tablet to help you divide it.
c) when to take it
SONE should be taken after meals at the time directed by your doctor.
d) how long to take it
Continue taking SONE as long as your doctor recommends it.
e) If you forget to take it
If your dosing schedule is one dose a day, take the missed dose as soon as possible, but not later than 4 hours before your next dose. If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking it as you would normally.
Do not take a double dose to make up for the dose that you missed.
If you are unsure about whether to take your next dose, speak to your doctor or pharmacist.
Do not try to make up for missed doses by taking more than one dose at a time.
This may increase the chance of you getting an unwanted side effect.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
If you take too much (Overdose):
Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to casualty at your nearest hospital, if you think that you or anyone else may have taken too much SONE. Do this even if there are no signs of discomfort or poisoning. Also report any other medicine or alcohol which has been taken. You may need urgent medical attention.
Keep telephone numbers for these places handy.
If you take too much SONE you may have the following symptoms: weakness, convulsions, dizziness, headache, nausea, vomiting, blurred vision, menstrual irregularities, and symptoms associated with electrolyte and fluid depletion and high blood pressure (hypertension).
While you are using SONE
Things you must do:
Use SONE exactly as your doctor has prescribed.
Tell all doctors, dentists and pharmacists who are treating you that you are taking SONE.
Tell your doctor (immediately) if you become pregnant while you are taking SONE.
Tell your doctor if you feel SONE is not helping your condition.
Visit your doctor regularly.
Your doctor needs to check your progress and see whether you need to keep taking SONE.
Always discuss with your doctor any problems or difficulties during or after taking SONE.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.
Otherwise your doctor may think that it was not effective and change your treatment unnecessarily.
Keep enough SONE to last weekends and holidays.
Things you must not do:
Do not take any other medicines while you are taking SONE without first telling your doctor.
Do not drive or operate machinery until you know how SONE affects you.
SONE may cause dizziness in some people and therefore may affect alertness.
Make sure you know how you react to SONE before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or have blurred vision.
Do not take SONE for a longer time than your doctor has prescribed.
Do not change your dose without first checking with your doctor.
Do not stop taking SONE or lower the dose, without first checking with your doctor.
Stopping this medicine suddenly on your own accord may cause some unwanted and dangerous effects, or your condition may reappear. Your doctor will advise you when you can stop taking SONE completely.
Do not use this medicine to treat any other complaints unless your doctor says to.
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Things to be careful of:
Some people may experience side effects such as nausea, headache, dizziness, acne, moonface, buffalo hump, flushing striae (red and dilated capillaries on the face or other parts of the body), increased appetite, osteoporosis, oedema (swelling) and hypertension (high blood pressure).
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking SONE.
SONE helps most people with medical conditions listed in the beginning of this information piece, but it may have unwanted side effects in some people.
All medicines have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Ask your doctor or pharmacist any questions you may have.
Common Side Effects:
Tell your doctor if you notice any of the following and they worry you:
• nausea (feeling sick)
• oedema (swelling)
• high blood pressure
• abdominal or stomach pain
• headache
• dizziness
• muscle weakness
• vomiting
• increased appetite
• increased sweating
• blurred vision
• skin rashes
There are other side effects which occur less often, for example growth suppression in children, effects on blood sugar control, effects on the heart. If you get watery and large amounts of urine, tell your doctor immediately.
There are other side effects like peptic ulceration, Cushing's Syndrome (swelling from oedemaand causing a moonface), delayed wound healing and increased susceptibility to infections of all kinds. These are all rare but serious side effects.
If you develop an infection, or severe headache, shortness of breath, severe palpitations, confusion or vision problems tell your doctor immediately.
Some people may get other side effects while taking SONE.
Your doctor may lower the dose to help control serious side effects and decide on necessary tests to monitor any of the above problems.
Check with your doctor as soon as possible if you have any problems while taking SONE even if you do not think the problems are connected with the medicine or are not listed in this information piece.
After using SONE
Storage
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Keep SONE in a cool dry place where the temperature stays below 30°C and protect from light.
Do not store it, or any other medicines, in a bathroom or near a sink.
Do not leave it in the car or on window sills.
Heat and dampness can destroy some medicines.
Do not take SONE if the tablets do not look quite right.
Keep your tablets in the bottle they were provided in until it is time to take them.
Disposal
If your doctor tells you to stop taking the tablets OR they have passed their expiry date, ask your pharmacist what to do with any left over.
Product description
a) What it looks like
SONE 5 mg tablet is a white round plain uncoated tablet.
SONE 25 mg tablet is a white round plain uncoated tablet, one side plain and the other scored.
b) Ingredients
Each SONE 5 mg tablet contains 5mg of the active ingredient prednisone.
The excipients or other non-active ingredients are:
• lactose
• propyl hydroxybenzoate
• starch-maize
• starch-wheat
• gelatin
• magnesium stearate
Each SONE 25 mg tablet contains 25mg of the active ingredient prednisone.
The excipients or other non-active ingredients are:
• lactose
• propyl hydroxybenzoate
• starch-maize
• starch-wheat
• gelatin
• magnesium stearate
SONE contains lactose and gluten but does NOT contain sucrose.
Sponsor or Supplier
Sigma Pharmaceuticals (Australia) Pty Ltd (A.C.N. 004 118 594)
96 Merrindale Drive
Croydon Victoria 3136
Australia
Telephone: 03 - 9839 2800
The Australian Registration Number for SONE 5 mg tablet is AUST R 56129.
The Australian Registration Number for SONE 25 mg tablet is AUST R 13470.
This information was prepared in March 1997 and updated in February & December 2001.
Consumer Medicine Information
Disclaimer
This information answers some common questions about SONE (prednisone tablets).
It does not contain all of the available information about SONE tablets.
It does not replace talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you or your child taking SONE against the benefits he or she expects it will have.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
What is SONE
The name of your medicine is SONE and is available in tablets of two different strengths of 5 mg and 25 mg tablets.
The active ingredient is called prednisone.
Prednisone belongs to a group of medicines called corticosteroids.
Corticosteroids are used to help reduce inflammation in the body or to suppress the immune system in the body, when a disease may be due to an autoimmune reaction (where your body fights against itself).
SONE is available as a 5 mg and 25 mg tablet.
What SONE is used for
SONE is used to treat a number of medical conditions.
• Your doctor will be able to decide.
Ask your doctor if you have any questions about why SONE has been prescribed for you.
If you have any concerns, you should discuss this with your doctor.
This medicine is available only with a doctor's prescription.
Before you take SONE
When you must not take it
Do not take SONE if you are allergic to:
• Prednisone or other cortisone type medications, or any of the ingredients listed at the end of this information piece including lactose.
Some of the symptoms of an allergic reaction to SONE may include urticaria and other skin rashes, difficulty breathing, hay fever, swelling of the face or throat or faintness.
Do not take SONE if you have a peptic ulcer, suffer from osteoporosis (brittle bones) or suffer severe psychoneuroses.
Do not take SONE if you are breastfeeding or plan to breastfeed.
Do not take SONE if you know you have any infections, including mumps, measles or
chickenpox.
Do not use SONE after the expiry date (EXP.) printed on the pack.
If you take it after the expiry date has passed, it may have no effect at all, or worse, there may be an entirely unexpected effect.
Do not purchase or use SONE if the packaging is torn or shows any signs of tampering.
Do not give it to children unless your doctor has prescribed it.
Before you start to take it
You must tell your doctor if:
1. You are allergic to any other medicines or any foods, dyes or preservatives.
2. You have or have had any other medical conditions/ health problems, including:
• suffer from tuberculosis(TB)
• suffer from a stomach ulcer
• suffer from osteoporosis (brittle
bone disease)
• suffer from myasthenia gravis
• suffer from congestive heart failure or have any other heart disease
• have diabetes
• have renal failure (your kidneys have shutdown)
• have an underactive thyroid gland (hypothyroidism)
• have any infection (bacterial or fungal) including viral infections such as chicken pox.
3. Take Typhoid Vaccine.
Live or attenuated vaccines such as oral typhoid vaccine must not be taken with SONE.
4. You are pregnant or plan to become pregnant.
SONE like all medicines should not be used during pregnancy, unless your doctor tells you.
5. You are breastfeeding or plan to breastfeed.
6. You are taking potassium supplements.
7. You are taking some anti-epileptic drugs
8. You are taking growth hormones
9. You are taking digoxin or digitalis glycosides.
10. You are on a course of vaccinations.
If you have not told your doctor about any of the above, tell them before you take any SONE.
Taking other medicines
Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.
Some medicines may interfere with SONE. These include:
• medicines used to treat upset stomachs such as antacids
• medicines used for diabetes including insulin
• medicines used to treat tuberculosis such as rifampicin
• medicines used to treat fungal infections such as ketoconazole
• some medicines which have a high sodium content and also foods with a high sodium content - check with your pharmacist
• some fluid tablets, also called diuretics
• alcohol
• barbiturates, medicine used to treat epilepsy
• high doses of aspirin
The above medicines may either reduce the effectiveness of SONE, reduce its own effectiveness and/or react with SONE resulting in untoward or sometimes dangerous side effects.
SONE will interfere with laboratory tests your doctor may make to check your thyroid. Tell your doctor if you are taking SONE tablets before you undergo any laboratory test.
This list is not exhaustive. Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking SONE.
How to take SONE
a) how much to take
The dose of SONE may be different for each person and their medical condition.
Your doctor will decide the right dose for you.
The recommended doses are for:
• Adults: 10 mg to 100 mg daily in divided doses.
• Children: 1 to 5 years: 2.5 mg to 10 mg twice daily.
• Children: 6 to 12 years: 5 mg to 20 mg twice daily.
However, dosage requirements are variable and are individualised by your doctor based on the treatment you are undergoing and your response to it.
High doses of SONE should be reduced gradually. Your doctor will know how.
b) how to take it
Swallow the medicine with water. If the dose is one-half tablet, there is a break-line on the tablet to help you divide it.
c) when to take it
SONE should be taken after meals at the time directed by your doctor.
d) how long to take it
Continue taking SONE as long as your doctor recommends it.
e) If you forget to take it
If your dosing schedule is one dose a day, take the missed dose as soon as possible, but not later than 4 hours before your next dose. If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking it as you would normally.
Do not take a double dose to make up for the dose that you missed.
If you are unsure about whether to take your next dose, speak to your doctor or pharmacist.
Do not try to make up for missed doses by taking more than one dose at a time.
This may increase the chance of you getting an unwanted side effect.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
If you take too much (Overdose):
Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to casualty at your nearest hospital, if you think that you or anyone else may have taken too much SONE. Do this even if there are no signs of discomfort or poisoning. Also report any other medicine or alcohol which has been taken. You may need urgent medical attention.
Keep telephone numbers for these places handy.
If you take too much SONE you may have the following symptoms: weakness, convulsions, dizziness, headache, nausea, vomiting, blurred vision, menstrual irregularities, and symptoms associated with electrolyte and fluid depletion and high blood pressure (hypertension).
While you are using SONE
Things you must do:
Use SONE exactly as your doctor has prescribed.
Tell all doctors, dentists and pharmacists who are treating you that you are taking SONE.
Tell your doctor (immediately) if you become pregnant while you are taking SONE.
Tell your doctor if you feel SONE is not helping your condition.
Visit your doctor regularly.
Your doctor needs to check your progress and see whether you need to keep taking SONE.
Always discuss with your doctor any problems or difficulties during or after taking SONE.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.
Otherwise your doctor may think that it was not effective and change your treatment unnecessarily.
Keep enough SONE to last weekends and holidays.
Things you must not do:
Do not take any other medicines while you are taking SONE without first telling your doctor.
Do not drive or operate machinery until you know how SONE affects you.
SONE may cause dizziness in some people and therefore may affect alertness.
Make sure you know how you react to SONE before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or have blurred vision.
Do not take SONE for a longer time than your doctor has prescribed.
Do not change your dose without first checking with your doctor.
Do not stop taking SONE or lower the dose, without first checking with your doctor.
Stopping this medicine suddenly on your own accord may cause some unwanted and dangerous effects, or your condition may reappear. Your doctor will advise you when you can stop taking SONE completely.
Do not use this medicine to treat any other complaints unless your doctor says to.
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Things to be careful of:
Some people may experience side effects such as nausea, headache, dizziness, acne, moonface, buffalo hump, flushing striae (red and dilated capillaries on the face or other parts of the body), increased appetite, osteoporosis, oedema (swelling) and hypertension (high blood pressure).
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking SONE.
SONE helps most people with medical conditions listed in the beginning of this information piece, but it may have unwanted side effects in some people.
All medicines have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Ask your doctor or pharmacist any questions you may have.
Common Side Effects:
Tell your doctor if you notice any of the following and they worry you:
• nausea (feeling sick)
• oedema (swelling)
• high blood pressure
• abdominal or stomach pain
• headache
• dizziness
• muscle weakness
• vomiting
• increased appetite
• increased sweating
• blurred vision
• skin rashes
There are other side effects which occur less often, for example growth suppression in children, effects on blood sugar control, effects on the heart. If you get watery and large amounts of urine, tell your doctor immediately.
There are other side effects like peptic ulceration, Cushing's Syndrome (swelling from oedemaand causing a moonface), delayed wound healing and increased susceptibility to infections of all kinds. These are all rare but serious side effects.
If you develop an infection, or severe headache, shortness of breath, severe palpitations, confusion or vision problems tell your doctor immediately.
Some people may get other side effects while taking SONE.
Your doctor may lower the dose to help control serious side effects and decide on necessary tests to monitor any of the above problems.
Check with your doctor as soon as possible if you have any problems while taking SONE even if you do not think the problems are connected with the medicine or are not listed in this information piece.
After using SONE
Storage
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Keep SONE in a cool dry place where the temperature stays below 30°C and protect from light.
Do not store it, or any other medicines, in a bathroom or near a sink.
Do not leave it in the car or on window sills.
Heat and dampness can destroy some medicines.
Do not take SONE if the tablets do not look quite right.
Keep your tablets in the bottle they were provided in until it is time to take them.
Disposal
If your doctor tells you to stop taking the tablets OR they have passed their expiry date, ask your pharmacist what to do with any left over.
Product description
a) What it looks like
SONE 5 mg tablet is a white round plain uncoated tablet.
SONE 25 mg tablet is a white round plain uncoated tablet, one side plain and the other scored.
b) Ingredients
Each SONE 5 mg tablet contains 5mg of the active ingredient prednisone.
The excipients or other non-active ingredients are:
• lactose
• propyl hydroxybenzoate
• starch-maize
• starch-wheat
• gelatin
• magnesium stearate
Each SONE 25 mg tablet contains 25mg of the active ingredient prednisone.
The excipients or other non-active ingredients are:
• lactose
• propyl hydroxybenzoate
• starch-maize
• starch-wheat
• gelatin
• magnesium stearate
SONE contains lactose and gluten but does NOT contain sucrose.
Sponsor or Supplier
Sigma Pharmaceuticals (Australia) Pty Ltd (A.C.N. 004 118 594)
96 Merrindale Drive
Croydon Victoria 3136
Australia
Telephone: 03 - 9839 2800
The Australian Registration Number for SONE 5 mg tablet is AUST R 56129.
The Australian Registration Number for SONE 25 mg tablet is AUST R 13470.
This information was prepared in March 1997 and updated in February & December 2001.
